Granules India Limited announced today that its US subsidiary has received approval from the Food and Drug Administration (FDA) for generic Bupropion Hydrochloride Extended-Release Tablets. The approval covers three strengths – 100 mg, 150 mg, and 200 mg of the antidepressant medication.
The shares of Granules India Limited were trading at ₹595.45 up by ₹1 or 0.17 per cent on the NSE today at 1.10 pm.
The approved generic is therapeutically equivalent to GlaxoSmithKline’s Wellbutrin SR, which is prescribed for major depressive disorder and seasonal affective disorder. The approval, secured through Granules Pharmaceuticals Inc., brings the company’s total ANDA approvals from the FDA to 67.
“This ANDA approval marks a significant milestone in our journey to expand Granules’ presence in the US market,” said Dr Krishna Prasad Chigurupati, Chairman and Managing Director of Granules India Limited.
Headquartered in Hyderabad, Granules India operates 10 manufacturing facilities, with eight in India and two in the USA. The company manufactures across the pharmaceutical value chain, including Active Pharmaceutical Ingredients, Pharmaceutical Formulation Intermediates, and Finished Dosages. Its products are distributed to over 300 customers across more than 80 countries in regulated and semi-regulated markets.
